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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048478 |
Receipt No. | R000055222 |
Scientific Title | A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/27 |
Basic information | ||
Public title | A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity | |
Acronym | ACT-1 study | |
Scientific Title | A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity | |
Scientific Title:Acronym | ACT-1 study | |
Region |
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Condition | ||
Condition | taxane-induced peripheral neurotoxicity | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change in average pain intensity between baseline and week 16. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Acupuncture | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Patient with breast cancer who had received curative treatment more than 3 months ago
2) Received taxane. 3) Have "mild" or severer symptom in PRO-CTCAE item 39b 4) 18 years or older 5) ECOG PS 0 or 1 |
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Key exclusion criteria | 1)Patient with peripheral neuropathy by other than taxane
2)have distant metastases or local recurrence 3)have fibromyalgia, inflammatory joint disease, or phantom limb pain 4)undergoing chemotherapy 5)have mental illness 6)have severe comorbidities 7)being pregnant or breastfeeding 8)history of acupuncture for CIPN |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital | ||||||
Division name | Department of Palliative Medicine | ||||||
Zip code | 1040045 | ||||||
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo | ||||||
TEL | 0335422511 | ||||||
esatomi@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Cancer Center Hospital | ||||||
Division name | Department of Palliative Medicine | ||||||
Zip code | 1040045 | ||||||
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo | ||||||
TEL | 0335422511 | ||||||
Homepage URL | |||||||
hishiki@ncc.go.jp |
Sponsor | |
Institute | National Cancer Center Hospiatl
Department of Palliative Medicine |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | National Cancer Center Institutional Review Board |
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo |
Tel | 0335422511 |
irst@ml.res.ncc.go.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055222 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |